Pulse Oximetry- Evaluating Resp Rate- PCBA-1

December 5, 2013 updated by: Medtronic - MITG

Respiration Rate Parameter Studies in Healthy Volunteers Using a Bedside Respiratory Patient Monitoring System With the Multi-Functional Patient Monitoring PCBA-1

To assess performance of resp rate parameter in a monitoring system PCBA-1

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Covidien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy Subjects

Description

Inclusion Criteria:

  1. Male or female subjects ages 18 or older.
  2. Subject is willing and able to provide written consent.

Exclusion Criteria:

  1. Subject has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors.
  2. Subjects with abnormalities that may prevent proper application of the device.
  3. Subjects with significant Arrhythmia, as determined by subject self-report during screening and I/E criteria assessment at study start. (Three events of irregularities in radial pulse within thirty seconds).
  4. Women who are pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ME (mean error) of Respiration Rate values for each subject
Time Frame: 1-2 hours per subject
1-2 hours per subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

November 29, 2012

First Submitted That Met QC Criteria

February 12, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

December 6, 2013

Last Update Submitted That Met QC Criteria

December 5, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • COVMOPR0304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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